Quality Assurance, Associate Director or Senior Manager
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Associate Director or Senior Manager of Quality Assurance
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Summary of Position
The Associate Director (AD) or Senior Manager (SM), Quality Assurance (QA) is responsible for ensuring compliance with all applicable GxP (including GCP and GMP) regulations. This includes Quality oversight of all clinical activities at clinical sites and supporting contract research organizations (CROs), Contract manufacturers (CMOs), and other GxP-related providers as needed, global health authority requirements ensuring patient safety, strategic planning for continuous improvement efforts, reporting/escalation of critical quality issues, site qualifications/audits, regulatory agency inspections and responses thereto, risk mitigation, and ensuring a compliant culture of quality throughout Anavex.
Key Responsibilities
- Management and direct oversight of all GCP and GMP activities related to FDA and ROW regulations for clinical programs and chemistry, manufacturing, and control (CMC) activities at and on behalf of Anavex, including all GxP activities at clinical sites, CMOs, CROs, and raw material suppliers
- Lead efforts to develop, implement and provide oversight of Anavex's Quality Management Systems (QMS), addressing Quality Agreements, SOPs, CAPAs, CSRs, stats output, etc
- Perform and direct audits of external suppliers and internal systems
- Host audits in conjunction with Anavex management with regulatory authorities
- Development and implementation of strategies to ensure compliance with applicable regulatory requirements
- Implement strategic audit plans for all compounds across all stages of development
- Report significant investigation/deviation issues and system deficiencies to senior management, as appropriate, and facilitate corrective actions
- Develop an inspection readiness program and represent the company during regulatory inspections
- Provide organizational direction to ensure responses to quality-related regulatory queries are timely and complete
- Support quality activities during due diligence
- Advise executive management on developments in regulations and standards related to GxP quality that may impact company strategies and programs
Requirements
- Minimum of a Bachelor's degree in Biology, Chemistry, or related fields; advanced degree preferred
- A minimum of Associate Director 6-10 years and Senior Manager 3-5 years in the pharmaceutical/biotechnology sector including both GCP and GMP Quality for Phase 1-3 clinical trials. Commercial stage product experience a plus
- Expert knowledge of FDA and EMA GMP, GCP, and regulatory requirements, ICH guidelines, and industry standards
- Experience in assisting in the development and implementation of a company quality management system
- Experience conducting GCP/GMP audits
- Experience dealing with FDA, EMEA, and other global health authority quality activities
- Experience with assisting in the building of a GCP/GMP culture in a start-up pharmaceutical/biotechnology company is preferred
- Experience with assisting in the successful management of inspection readiness programs and FDA and global regulatory inspections
Your Path to Unique Opportunities
If you're looking to push the envelope and join an innovative company where technology meets therapeutic discovery and development and you're enthusiastic, creative, with a passion for cutting-edge research, you should join our team! We are looking for highly motivated, passionate employees to help us drive technology solutions for discovering breakthrough treatments for our portfolio of rare disease and neuroscience programs.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer's disease, Parkinson's disease, Rett syndrome and other central nervous system (CNS) diseases, pain, and various types of cancer. Further information is available at www.anavex.com .
EOE/M/F/V/SO Anavex Life Sciences Corp. is an Equal Opportunity Employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, gender identity, sexual orientation or protected veteran status. Visit anavex.com/eeo-policy-statement to access our complete Equal Employment Opportunity statement. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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